Sr. Manager-Director, Regulatory Affairs (Respiratory)

REPORTING RELATIONSHIPS

Will report to President, R&D, USA. May be responsible for managing up to 2 RA staff including U.S. and India.

DUTIES & ESSENTIAL JOB FUNCTIONS

This position is responsible for all Regulatory Strategy and Filing aspects of MDI aerosols development, including CMC and possibly, Clinical strategy.

OTHER FUNCTIONS AND RESPONSIBILITIES

• Keep abreast of new Regulatory and Scientific developments in the Respiratory area.

• Additionally take on Derma & Transdermal RA responsibilities.

QUALIFICATIONS

• Regulatory experience supporting Generic Respiratory MDI aerosols development is a must!

• Good scientific/technical understanding of the MDI aerosols space

• Excellent written and spoken communication skills

• Excellent interpersonal skills

• Attention to details, quality and follow-through

• Project management and excellent time-management and organization skills

• Excellent analytical skills and problem solving ability

DUTIES & ESSENTIAL JOB FUNCTIONS

40% - Develop and provide Strategic Regulatory guidance/advice to Project Teams

30% - Manage all Regulatory aspects of Respiratory ANDA filings

20% - FDA interactions via e-mail, tel., mtgs, conferences

5% - Provide updates to senior & executive management

5% - Recruiting, training, team building

JOB DESCRIPTION

Education:

Master’s/PhD – in Chemistry/Pharm. Sciences

Experience:

• Must have MDI generics filing experience (not Nasal or other dosage forms); interacting with the FDA, developing Regulatory strategy

• 8 + years total, and in MDI aerosol generics – 5+ years

• Experience with regulatory agency interactions and preparation of documents for regulatory agency interactions

Thanks

Warm regards
Avleen Kaur
732-318-6945

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